Cl II Siemens ACUSON Virtual Touch IQ option

Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report: 8/52015
Class lI:


ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
Recall Number Z-2321-2015

Potential measurement error on your ACUSON S Family ultrasound system when repositioning the Virtual Touch IQ region of interest from the original (default) location, the lateral position of the measurement tool may not align with the lateral position. of the shear velocity data.

Siemens Medical Solutions USA, Inc, Mountainview, CA on 6/25/2015 Voluntary: Firm Initiated recall is ongoing

629 units

Nationwide and Internationally


About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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